Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Reduction
研究概览
简要总结
Osteoarthritis (OA) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. With 25% of Canadians expected to be aged 55 or older by 2036, an increasing number of Canadians will be impacted by knee OA. In affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. Current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. These current conservative measures have variable responses. In patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking.
Geniculate artery embolization (GAE) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. GAE provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VAS score of at least 50 mm for knee pain
- •Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
- •Age > 40 years
- •Radiographs demonstrating knee osteoarthritis on same side as pain
- •Patient not a surgical candidate or declines surgical management
排除标准
- •Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade >2)
- •Severe non-knee related lower limb pain with VAS > 50 mm.
- •Local infection and inflammatory arthritis.
- •Previous knee surgery
- •Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR > 1.4, pre-procedure PTT > 40 seconds or pre-procedure platelets < 50,000/uL
- •Known chronic renal failure or eGFR < 45
- •ECOG grade > 2
- •Patient weight > 300 lbs
- •Patient unreliable for follow up
结局指标
主要结局
Pain Reduction
时间窗: 3 months
To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis
次要结局
- Procedure related complications(30 days)
- Pain Reduction(1 month and 6 months)
- Pain, stiffness and physical function(1, 3 and 6 months)
- Pain medication required(1, 3, and 6 months)